Clinical trial Recruiting at 8 sites Observational Ages 18 and up

Monitoring patients with abdominal aortic aneurysms before and after surgery

Official title: Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair

Run by ViTAA Medical Solutions · NCT05004051 · Data updated 2026-11-12

This study is trying to see how well a new imaging technology works for monitoring patients with abdominal aortic aneurysms before and after they have surgery.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorViTAA Medical Solutions
Industry-sponsored
Locations8 sites (Birmingham, Alabama and 7 other locations)
StatusRecruiting
StartedDecember 15, 2021
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedSeptember 19, 2025
Trial IDNCT05004051 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with infrarenal aortic aneurysms measuring 45 mm or more in diameter.

Probably not a fit

Patients with major connective tissue disorders, renal failure, or previous aortic reconstruction in the involved segment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects imaging and clinical data from patients with abdominal aortic aneurysms undergoing endovascular repair and those in a serial monitoring program. The study utilizes ViTAA aortic mapping technology to assess patients at multiple centers across the US and Canada. Participants include those scheduled for endovascular repair and those who do not yet meet the criteria for surgery but require ongoing monitoring.

Why it matters

Potential benefit: If successful, this study could enhance the management and outcomes of patients with abdominal aortic aneurysms through improved monitoring techniques.

How similar studies have gone: Other studies utilizing registry approaches for monitoring aortic aneurysms have shown promise, indicating potential for success in this study as well.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patient is aged 18 years or over
2. Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
3. Patient meets on-IFU criteria for endovascular reconstruction

Exclusion Criteria:

1. Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.
2. Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L
3. Patients with previous aortic reconstruction in the involved segment.
4. Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).
5. Patient has a sensitivity to contrast imaging agents.
6. Patient has aortic dissection.
7. Patient has atrial fibrillation.
8. Patient has arrhythmia.

Where it's running

  • UAB - University of Alabama in Birmingham Hospital
    Birmingham, Alabama, United States
    Recruiting
  • MGH - Massachusetts General Hospital Fireman Vascular Center
    Boston, Massachusetts, United States
    Recruiting
  • UNC - University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina, United States
    Recruiting
  • University of Washington
    Seattle, Washington, United States
    Recruiting
  • UCGY - University of Calgary, Peter Lougheed Center
    Calgary, Alberta, Canada
    Recruiting
  • UHN - University Health Network - Toronto General Hospital
    Toronto, Ontario, Canada
    Recruiting
Show 2 more locations
  • CHUM - Centre Hospitalier de l'Université de Montréal
    Montreal, Quebec, Canada
    Recruiting
  • MUHC - McGill University Health Centre
    Montreal, Quebec, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.